retatrutide nejm 2023 obesity trial ly3437943 (LY3437943) — Dosing, Side Effects, FDA Status & Research | PeptIQ A Study of Retatrutide (LY3437943)

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C.ChenT.PasterB

Cecilia Low Wang, a UCHealth expert on endocrinology, diabetes and metabolism

This has led to drug approval being sought under the Food and Drug Administration's subpart H pathway in the United States, in which short-term improvement in histology, based on the mechanism of action of a drug, allows conditional approval with the requirement that additional studies are undertaken to demonstrate that short-term changes translate into reduced progression to cirrhosis and its complications

Discarded right ventricular tissue from congenital heart defect surgery (pulmonary valve repair) was obtained with patients parents or legal guardians informed consent (ethical approval 15/LO/1064 from the North Somerset and South Bristol Research Ethics Committee)

Thus, the current results need to be replicated in a larger sample, and more studies are needed to determine whether endogenous or exogenous GLP-1 or analogs can affect the reproductive axis directly in men